Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial

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Abstract

Background

Data and Safety Monitoring is integral to quality assurance of clinical trials. Although monitoring is a core legal component of regulated clinical trials, non-regulated trials are not mandated to incorporate monitoring. Consequently, the monitoring process has been underutilised and underreported in this setting. This research report outlines the development and plans for implementing a bespoke Clinical Monitoring Strategy within the ‘ Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) Trial’ , a non-regulated trial comparing a 12-week multidisciplinary programme of rehabilitation to standard care in a cohort of 120 cancer survivors.

Methods

This research note provides a detailed overview of the ReStOre II Clinical Monitoring Strategy and describes the development of the strategy pre and post awarding of the grant. The strategy consists of the establishment and implementation of a comprehensive trial governance structure, inclusive of a Trial Management Group, Trial Steering Committee Meeting, and Independent Data Monitoring Committee. In addition, external trial monitoring by the Clinical Research Facility at St James’s Hospital. Three monitoring visits will be conducted during the trial; i) site initiation visit, ii) interim monitoring visit, and iii) close our visit.

Results

The Clinical Monitoring Strategy has been finalised and is currently being implemented within the ReStOre II Trial. Two site initiation visits and one interim monitoring visit have been completed to date.

Conclusion

This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial.

Registration

ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019

Related collections

Most cited references 21

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The RESTORE Randomized Controlled Trial

Juliette Hussey, John Reynolds, Linda O’Neill … (2018)

The Rehabilitation Strategies in Esophagogastric cancer (RESTORE) randomized controlled trial evaluated the efficacy of a 12-week multidisciplinary program to increase the cardiorespiratory fitness and health-related quality of life (HRQOL) of esophagogastric cancer survivors.

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Is Open Access

Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study

Oana Brosteanu, Gabriele Schwarz, Peggy Houben … (2017)

Background According to Good Clinical Practice, clinical trials must protect rights and safety of patients and make sure that the trial results are valid and interpretable. Monitoring on-site has an important role in achieving these objectives; it controls trial conduct at trial sites and informs the sponsor on systematic problems. In the past, extensive on-site monitoring with a particular focus on formal source data verification often lost sight of systematic problems in study procedures that endanger Good Clinical Practice objectives. ADAMON is a prospective, stratified, cluster-randomised, controlled study comparing extensive on-site monitoring with risk-adapted monitoring according to a previously published approach. Methods In all, 213 sites from 11 academic trials were cluster-randomised between extensive on-site monitoring (104) and risk-adapted monitoring (109). Independent post-trial audits using structured manuals were performed to determine the frequency of major Good Clinical Practice findings at the patient level. The primary outcome measure is the proportion of audited patients with at least one major audit finding. Analysis relies on logistic regression incorporating trial and monitoring arm as fixed effects and site as random effect. The hypothesis was that risk-adapted monitoring is non-inferior to extensive on-site monitoring with a non-inferiority margin of 0.60 (logit scale). Results Average number of monitoring visits and time spent on-site was 2.1 and 2.7 times higher in extensive on-site monitoring than in risk-adapted monitoring, respectively. A total of 156 (extensive on-site monitoring: 76; risk-adapted monitoring: 80) sites were audited. In 996 of 1618 audited patients, a total of 2456 major audit findings were documented. Depending on the trial, findings were identified in 18%–99% of the audited patients, with no marked monitoring effect in any of the trials. The estimated monitoring effect is −0.04 on the logit scale with two-sided 95% confidence interval (−0.40; 0.33), demonstrating that risk-adapted monitoring is non-inferior to extensive on-site monitoring. At most, extensive on-site monitoring could reduce the frequency of major Good Clinical Practice findings by 8.2% compared with risk-adapted monitoring. Conclusion Compared with risk-adapted monitoring, the potential benefit of extensive on-site monitoring is small relative to overall finding rates, although risk-adapted monitoring requires less than 50% of extensive on-site monitoring resources. Clusters of findings within trials suggest that complicated, overly specific or not properly justified protocol requirements contributed to the overall frequency of findings. Risk-adapted monitoring in only a sample of patients appears sufficient to identify systematic problems in the conduct of clinical trials. Risk-adapted monitoring has a part to play in quality control. However, no monitoring strategy can remedy defects in quality of design. Monitoring should be embedded in a comprehensive quality management approach covering the entire trial lifecycle.

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Sarcopenia during neoadjuvant therapy for oesophageal cancer: characterising the impact on muscle strength and physical performance.

Emer M Guinan, S Doyle, A. E. Bennett … (2018)

Preoperative chemo(radio)therapy for oesophageal cancer (OC) may have an attritional impact on body composition and functional status, impacting postoperative outcome. Physical decline with skeletal muscle loss has not been previously characterised in OC and may be amenable to physical rehabilitation. This study characterises skeletal muscle mass and physical performance from diagnosis to post-neoadjuvant therapy in patients undergoing preoperative chemo(radio)therapy for OC.

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Author and article information

Contributors

Linda O'Neill: Role: MethodologyRole: Project AdministrationRole: Writing – Original Draft PreparationRole: Writing – Review & Editing

ORCID: https://orcid.org/0000-0002-0109-9650

Fiona Murphy: Role: Project AdministrationRole: Writing – Original Draft PreparationRole: Writing – Review & Editing

ORCID: https://orcid.org/0009-0006-8796-1104

Derval Reidy: Role: Project AdministrationRole: Writing – Review & Editing

Camille Poisson: Role: MethodologyRole: Project AdministrationRole: Writing – Review & Editing

ORCID: https://orcid.org/0009-0005-5853-2127

Juliette Hussey: Role: Funding AcquisitionRole: MethodologyRole: Project AdministrationRole: Writing – Review & Editing

Emer Guinan: Role: ConceptualizationRole: MethodologyRole: Writing – Review & Editing

ORCID: https://orcid.org/0000-0001-9715-146X

Journal

Journal ID (nlm-ta): HRB Open Res

Journal ID (iso-abbrev): HRB Open Res

Title: HRB Open Research

Publisher: F1000 Research Limited (London, UK )

ISSN (Electronic): 2515-4826

Publication date (Electronic): 6 December 2023

Publication date Collection: 2023

Volume: 6

Electronic Location Identifier: 46

Affiliations

[1 ]School of Medicine, Discipline of Physiotherapy, Trinity College, Dublin, Ireland

[2 ]Trinity St James's Cancer Institute, Trinity College, St James's Hospital, Dublin, Ireland

[3 ]School of Pharmacy and Pharmaceutical Sciences, Trinity College, Dublin, Ireland

[4 ]Wellcome-Health Research Board Clinical Research Facility, Trinity College, St James’s Hospital, Dublin, Ireland

[5 ]Research Innovation, Trinity College, Trinity College Dublin, the University of Dublin, Dublin, Ireland

[6 ]Trinity Innovation & Enterprise, Trinity College, Hartford, Connecticut, USA

[1 ]MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, England, UK

[1 ]RCSI Sponsorship Office, Royal College of Surgeons in Ireland, Dublin, Ireland

[1 ]Baptist Health South Florida,, Miami Cancer Institute,, Miami,, Florida, USA

[2 ]School of Public Health, Johns Hopkins Bloomberg, Baltimore, Maryland, USA

[1 ]MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, England, UK

Department of Surgery, Trinity College, Dublin, Dublin, Ireland

[1 ]RCSI Sponsorship Office, Royal College of Surgeons in Ireland, Dublin, Ireland

Department of Surgery, Trinity College, Dublin, Dublin, Ireland

Author notes

[a ] emguinan@ 123456tcd.ie

No competing interests were disclosed.

Competing interests: No competing interests were disclosed.

Competing interests: No competing interests

Competing interests: No competing interests were disclosed.

Competing interests: No competing interests

Author information

Linda O'Neill https://orcid.org/0000-0002-0109-9650

Fiona Murphy https://orcid.org/0009-0006-8796-1104

Camille Poisson https://orcid.org/0009-0005-5853-2127

Emer Guinan https://orcid.org/0000-0001-9715-146X

Article

DOI: 10.12688/hrbopenres.13763.2

PMC ID: 11401978

PubMed ID: 39280895

SO-VID: 74b4c7b5-7f32-4257-b6da-4c1ac90cd299

License:

This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Date accepted : 4 December 2023

Funding

Funded by: Health Research Board

Award ID: HRB-DIFA-2018-009

Health Research Board Ireland [DIFA-FA-2018-009]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial

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Abstract

Background

Methods

Results

Conclusion

Registration

Related collections

Chinese Journal of Radiological Health

Most cited references 21

The RESTORE Randomized Controlled Trial

Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study

Sarcopenia during neoadjuvant therapy for oesophageal cancer: characterising the impact on muscle strength and physical performance.

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